Intravascular devices, systems, and methods having a core wire with embedded conductors

ABSTRACT

Intravascular devices, systems, and methods are disclosed. In some instances, the intravascular device is a guide wire with electrical conductors embedded within a core wire. In some instances, the electrical conductors are coupled to conductive bands adjacent a proximal portion of the guide wire and a sensing element adjacent a distal portion of the guide wire. Methods of making, manufacturing, and/or assembling such intravascular devices and associated systems are also provided.

CROSS REFERENCE TO RELATED APPLICATION

The present application is a continuation of U.S. patent applicationSer. No. 14/611,921, filed Feb. 2, 2015, now U.S. Pat. No. 9,955,878,which claims priority to and the benefit of U.S. Provisional PatentApplication No. 61/935,113 filed Feb. 3, 2014, each of which is herebyincorporated by reference herein in its entirety.

TECHNICAL FIELD

The present disclosure relates to intravascular devices, systems, andmethods. In some embodiments, the intravascular devices are guide wiresthat include a core wire having one or more embedded conductors.

BACKGROUND

Heart disease is very serious and often requires emergency operations tosave lives. A main cause of heart disease is the accumulation of plaqueinside the blood vessels, which eventually occludes the blood vessels.Common treatment options available to open up the occluded vesselinclude balloon angioplasty, rotational atherectomy, and intravascularstents. Traditionally, surgeons have relied on X-ray fluoroscopic imagesthat are planar images showing the external shape of the silhouette ofthe lumen of blood vessels to guide treatment. Unfortunately, with X-rayfluoroscopic images, there is a great deal of uncertainty about theexact extent and orientation of the stenosis responsible for theocclusion, making it difficult to find the exact location of thestenosis. In addition, though it is known that restenosis can occur atthe same place, it is difficult to check the condition inside thevessels after surgery with X-ray.

A currently accepted technique for assessing the severity of a stenosisin a blood vessel, including ischemia causing lesions, is fractionalflow reserve (FFR). FFR is a calculation of the ratio of a distalpressure measurement (taken on the distal side of the stenosis) relativeto a proximal pressure measurement (taken on the proximal side of thestenosis). FFR provides an index of stenosis severity that allowsdetermination as to whether the blockage limits blood flow within thevessel to an extent that treatment is required. The normal value of FFRin a healthy vessel is 1.00, while values less than about 0.80 aregenerally deemed significant and require treatment.

Often intravascular catheters and guide wires are utilized to measurethe pressure within the blood vessel, visualize the inner lumen of theblood vessel, and/or otherwise obtain data related to the blood vessel.To date, guide wires containing pressure sensors, imaging elements,and/or other electronic, optical, or electro-optical components havesuffered from reduced performance characteristics compared to standardguide wires that do not contain such components. For example, thehandling performance of previous guide wires containing electroniccomponents have been hampered, in some instances, by the limited spaceavailable for the core wire after accounting for the space needed forthe conductors or communication lines of the electronic component(s),the stiffness of the rigid housing containing the electroniccomponent(s), and/or other limitations associated with providing thefunctionality of the electronic components in the limited spaceavailable within a guide wire. Further, due to its small diameter, inmany instances the proximal connector portion of the guide wire (i.e.,the connector(s) that facilitate communication between the electroniccomponent(s) of the guide wire and an associated controller orprocessor) is fragile and prone to kinking, which can destroy thefunctionality of the guide wire. For this reason, surgeons are reluctantto remove the proximal connector from the guide wire during a procedurefor fear of breaking the guide wire when reattaching the proximalconnector. Having the guide wire coupled to the proximal connectorfurther limits the maneuverability and handling of the guide wire.

Further, a problem with existing pressure and flow guide wires is thatthey require a complex assembly of many discrete components. Thatcomplex assembly process has limitations on design performance of theguide wire. The use of separate conductive wires running down the lengthof the wire reduces the space available for more supportive cores andcan result in numerous issues during use due to poor solder joints withconductive bands, electrical shorts due to insulation issues, andbreakage of the delicate conductive wires.

Accordingly, there remains a need for improved intravascular devices,systems, and methods that include one or more electronic, optical, orelectro-optical components.

SUMMARY

The present disclosure is directed to intravascular devices, systems,and methods that include a guide wire having a core wire with embeddedelectrical conductors.

The present disclosure provides a more robust sensing guide wire thatavoids the assembly and performance issues of prior sensing guide wires.Guide wires of the present disclosure have a core wire with one or moreelectrical conductors embedded therein. The electrical conductors extendthe length of the core and act as the electrical pathway for sensorsignals. The electrical conductors can be electrically isolated from themain body or primary material of the core wire by an insulating layer.The electrical conductors can be exposed by removing surroundingportions of the core wire (e.g., by grinding, etching, ablating, etc.)at specific locations on each conductor to facilitate the creation ofelectrical connections. In that regard, a proximal section of theconductor can be electrically coupled to a proximal connector (e.g., oneor more conductive bands), while a distal section of the conductor canbe electrically coupled to a sensing element. In that regard, the distalsection of the conductor may be exposed for electrical connection aspart of a distal shaping process. In this manner, guide wires of thepresent disclosure can eliminate the need for a hypotube andsubstantially reduce the need for adhesives and solder in formation ofthe guide wire. Reducing the number of components necessary to assemblethe guide wires improves the robustness of the assembled guide wire byeliminating a multitude of processes and connection points that cancreate failure conditions.

Any type of sensor can be connected to guide wires of the presentdisclosure. In certain embodiments, only a single sensor is connected tothe guide wire. In other embodiments, multiple sensors are connected tothe guide wire. All of the sensors may be the same. Alternatively, thesensors may differ from each other and measure different characteristicsinside a vessel. Exemplary sensors are pressure, flow, and temperaturesensors. Generally, any type of pressure sensor may be used with theguide wires of the present disclosure, including piezoresistive, opticaland/or combinations thereof. In certain embodiments, the pressure sensorincludes a crystalline semi-conductor material. Similarly, any type offlow sensor may be used with guide wires of the present disclosure. Incertain embodiments, the flow sensor includes an ultrasound transducer,such as a Doppler ultrasound transducer. The guide wire can include botha pressure sensor and a flow sensor.

Another aspect of the present disclosure provides methods for measuringa characteristic inside a vessel. The methods can include providing asensing guide wire that includes a core wire with one or more embeddedelectrical conductors. The electrical conductors can be isolated fromthe main body of the core wire by an insulating layer. The conductivewires can be exposed at one or more locations along the core wire tofacilitate electrical connection to a proximal connector and/or asensing element. The guide wire is inserted into a vessel, and one ormore sensing elements of the guide wire measure one or morecharacteristics inside the vessel.

The present disclosure provides intravascular devices that are strongerand more durable than existing designs, while also easier tomanufacture. Embodiments of the present disclosure utilize a core memberintegrally embedded with one or more electrical conductors thatfacilitates the use of a larger core that provides better handling,strength, and durability than existing designs, which reduces thelikelihood of unwanted bending, kinking, and/or other damage to theintravascular device that can be detrimental to the function of thedevice.

Additional aspects, features, and advantages of the present disclosurewill become apparent from the following detailed description.

BRIEF DESCRIPTION OF THE DRAWINGS

Illustrative embodiments of the present disclosure will be describedwith reference to the accompanying drawings, of which:

FIG. 1 is a diagrammatic, schematic side view of an intravascular deviceaccording to an embodiment of the present disclosure.

FIG. 2 is a cross-sectional end view of the intravascular device of FIG.1 taken along section line 2-2 according to an embodiment of the presentdisclosure.

FIG. 3 is a diagrammatic perspective view of a core member of theintravascular device of FIGS. 1 and 2 according to an embodiment of thepresent disclosure.

FIG. 4 is a diagrammatic, schematic side view of the core member of FIG.3 according to an embodiment of the present disclosure.

FIG. 5 is a diagrammatic, schematic side view of a proximal portion ofan intravascular device according to an embodiment of the presentdisclosure.

FIG. 6 is a diagrammatic, schematic side view of a distal portion of anintravascular device according to an embodiment of the presentdisclosure.

DETAILED DESCRIPTION

For the purposes of promoting an understanding of the principles of thepresent disclosure, reference will now be made to the embodimentsillustrated in the drawings, and specific language will be used todescribe the same. It is nevertheless understood that no limitation tothe scope of the disclosure is intended. Any alterations and furthermodifications to the described devices, systems, and methods, and anyfurther application of the principles of the present disclosure arefully contemplated and included within the present disclosure as wouldnormally occur to one skilled in the art to which the disclosurerelates. In particular, it is fully contemplated that the features,components, and/or steps described with respect to one embodiment may becombined with the features, components, and/or steps described withrespect to other embodiments of the present disclosure. For the sake ofbrevity, however, the numerous iterations of these combinations will notbe described separately.

As used herein, “flexible elongate member” or “elongate flexible member”includes at least any thin, long, flexible structure that can beinserted into the vasculature of a patient. While the illustratedembodiments of the “flexible elongate members” of the present disclosurehave a cylindrical profile with a circular cross-sectional profile thatdefines an outer diameter of the flexible elongate member, in otherinstances all or a portion of the flexible elongate members may haveother geometric cross-sectional profiles (e.g., oval, rectangular,square, elliptical, etc.) or non-geometric cross-sectional profiles.Flexible elongate members include, for example, guide wires andcatheters. In that regard, catheters may or may not include a lumenextending along its length for receiving and/or guiding otherinstruments. If the catheter includes a lumen, the lumen may be centeredor offset with respect to the cross-sectional profile of the device.

In most embodiments, the flexible elongate members of the presentdisclosure include one or more electronic, optical, or electro-opticalcomponents. For example, without limitation, a flexible elongate membermay include one or more of the following types of components: a pressuresensor, a flow sensor, a temperature sensor, an imaging element, anoptical fiber, an ultrasound transducer, a reflector, a mirror, a prism,an ablation element, an RF electrode, a conductor, and/or combinationsthereof. Generally, these components are configured to obtain datarelated to a vessel or other portion of the anatomy in which theflexible elongate member is disposed. Often the components are alsoconfigured to communicate the data to an external device for processingand/or display. In some aspects, embodiments of the present disclosureinclude imaging devices for imaging within the lumen of a vessel,including both medical and non-medical applications. However, someembodiments of the present disclosure are particularly suited for use inthe context of human vasculature. Imaging of the intravascular space,particularly the interior walls of human vasculature can be accomplishedby a number of different techniques, including ultrasound (oftenreferred to as intravascular ultrasound (“IVUS”) and intracardiacechocardiography (“ICE”)) and optical coherence tomography (“OCT”). Inother instances, infrared, thermal, or other imaging modalities areutilized.

The electronic, optical, and/or electro-optical components of thepresent disclosure are often disposed within a distal portion of theflexible elongate member. As used herein, “distal portion” of theflexible elongate member includes any portion of the flexible elongatemember from the mid-point to the distal tip. As flexible elongatemembers can be solid, some embodiments of the present disclosure willinclude a housing portion at the distal portion for receiving theelectronic components. Such housing portions can be tubular structuresattached to the distal portion of the elongate member. Some flexibleelongate members are tubular and have one or more lumens in which theelectronic components can be positioned within the distal portion.

The electronic, optical, and/or electro-optical components and theassociated communication lines are sized and shaped to allow for thediameter of the flexible elongate member to be very small. For example,the outside diameter of the elongate member, such as a guide wire orcatheter, containing one or more electronic, optical, and/orelectro-optical components as described herein are between about 0.0007″(0.0178 mm) and about 0.118″ (3.0 mm), with some particular embodimentshaving outer diameters of approximately 0.014″ (0.3556 mm),approximately 0.018″ (0.4572 mm), and approximately 0.035″ (0.889 mm).As such, the flexible elongate members incorporating the electronic,optical, and/or electro-optical component(s) of the present applicationare suitable for use in a wide variety of lumens within a human patientbesides those that are part or immediately surround the heart, includingveins and arteries of the extremities, renal arteries, blood vessels inand around the brain, and other lumens.

“Connected” and variations thereof as used herein includes directconnections, such as being glued or otherwise fastened directly to, on,within, etc. another element, as well as indirect connections where oneor more elements are disposed between the connected elements.

“Secured” and variations thereof as used herein includes methods bywhich an element is directly secured to another element, such as beingglued or otherwise fastened directly to, on, within, etc. anotherelement, as well as indirect techniques of securing two elementstogether where one or more elements are disposed between the securedelements.

Referring now to FIG. 1, shown therein is a portion of an intravasculardevice 100 according to an embodiment of the present disclosure. In thatregard, the intravascular device 100 includes a flexible elongate member102 having a distal portion 104 adjacent a distal end 105 and a proximalportion 106 adjacent a proximal end 107. A component 108 is positionedwithin the distal portion 104 of the flexible elongate member 102proximal of the distal tip 105. Generally, the component 108 isrepresentative of one or more electronic, optical, or electro-opticalcomponents. In that regard, the component 108 is a pressure sensor, aflow sensor, a temperature sensor, an imaging element, an optical fiber,an ultrasound transducer, a reflector, a mirror, a prism, an ablationelement, an RF electrode, a conductor, and/or combinations thereof. Thespecific type of component or combination of components can be selectedbased on an intended use of the intravascular device. In some instances,the component 108 is positioned less than 10 cm, less than 5, or lessthan 3 cm from the distal tip 105. In some instances, the component 108is positioned within a housing of the flexible elongate member 102. Inthat regard, the housing is a separate component secured to the flexibleelongate member 102 in some instances. In other instances, the housingis integrally formed as a part of the flexible elongate member 102.

The intravascular device 100 also includes a connector 110 adjacent theproximal portion 106 of the device. In that regard, the connector 110 isspaced from the proximal end 107 of the flexible elongate member 102 bya distance 112. Generally, the distance 112 is between 0% and 50% of thetotal length of the flexible elongate member 102. While the total lengthof the flexible elongate member can be any length, in some embodimentsthe total length is between about 1300 mm and about 4000 mm, with somespecific embodiments have a length of 1400 mm, 1900 mm, and 3000 mm.Accordingly, in some instances the connector 110 is positioned at theproximal end 107. In other instances, the connector 110 is spaced fromthe proximal end 107. For example, in some instances the connector 110is spaced from the proximal end 107 between about 0 mm and about 1400mm. In some specific embodiments, the connector 110 is spaced from theproximal end by a distance of 0 mm, 300 mm, and 1400 mm.

The connector 110 is configured to facilitate communication between theintravascular device 100 and another device. More specifically, in someembodiments the connector 110 is configured to facilitate communicationof data obtained by the component 108 to another device, such as acomputing device or processor. Accordingly, in some embodiments theconnector 110 is an electrical connector. In such instances, theconnector 110 provides an electrical connection to one or moreelectrical conductors that extend along the length of the flexibleelongate member 102 and are electrically coupled to the component 108.As discussed below, in some embodiments the electrical conductors areembedded within a core of the flexible elongate member. In otherembodiments, the connector 110 is an optical connector. In suchinstances, the connector 110 provides an optical connection to one ormore optical communication pathways (e.g., fiber optic cable) thatextend along the length of the flexible elongate member 102 and areoptically coupled to the component 108. Similarly, in some embodimentsthe optical fibers are embedded within a core of the flexible elongatemember. Further, in some embodiments the connector 110 provides bothelectrical and optical connections to both electrical conductor(s) andoptical communication pathway(s) coupled to the component 108. In thatregard, it should be noted that component 108 is comprised of aplurality of elements in some instances. The connector 110 is configuredto provide a physical connection to another device, either directly orindirectly. In some instances, the connector 110 is configured tofacilitate wireless communication between the intravascular device 100and another device. Generally, any current or future developed wirelessprotocol(s) may be utilized. In yet other instances, the connector 110facilitates both physical and wireless connection to another device.

As noted above, in some instances the connector 110 provides aconnection between the component 108 of the intravascular device 100 andan external device. Accordingly, in some embodiments one or moreelectrical conductors, one or more optical pathways, and/or combinationsthereof extend along the length of the flexible elongate member 102between the connector 110 and the component 108 to facilitatecommunication between the connector 110 and the component 108. Inaccordance with the present disclosure, at least one of the electricalconductors and/or optical pathways is embedded within the core of theflexible elongate member 102. Generally, any number of electricalconductors, optical pathways, and/or combinations thereof can extendalong the length of the core of the flexible elongate member 102 betweenthe connector 110 and the component 108. In some instances, between oneand ten electrical conductors and/or optical pathways extend along thelength of the core of the flexible elongate member 102 between theconnector 110 and the component 108. The number of communicationpathways and the number of electrical conductors and optical pathwaysextending along the length of the core of the flexible elongate member102 is determined by the desired functionality of the component 108 andthe corresponding elements that define component 108 to provide suchfunctionality, the diameter of the flexible elongate member 102, and/orthe diameter of the conductors and/or optical fibers.

Referring now to FIGS. 2-6, shown therein are aspects of theintravascular devices of the present disclosure that includecommunication pathways (e.g., electrical conductors and/or opticalfibers) embedded within a core member and extending along the length ofthe device. In that regard, one of the major issues associated withexisting functional guide wires is poor mechanical performance ascompared to frontline guide wires. This performance loss is due in alarge part to the typical design of the guide wires that severely limitsthe space available for the core or core wire due to the need to run thecommunication lines along the length of the device between the core wireand a surrounding hypotube. For the sake of clarity and simplicity, theembodiments described below include three electrical conductors embeddedin a main core body, which may also be formed of a conductive material.Those skilled in the art will recognize that the concepts are applicableto intravascular devices that include virtually any number of electricalconductors and/or optical fibers extending along the length of the corewire. However, in most implementations the intravascular device willinclude between 1 and 10 communication pathways extending along thelength of the core wire between a proximal portion and a distal portionof the intravascular device.

Referring more specifically to FIG. 2, a cross-sectional end view of theintravascular device 100 taken along section line 2-2 of FIG. 1. Asshown, the flexible elongate member 102 is defined by a core member 120according to an embodiment of the present disclosure. The core member120 defines a main body having an outer surface 122. In some instances,the outer diameter of the core member 120 defined by the outer surface122 is the same or substantially the same as the desired outer diameterof the intravascular device 100 that the core member 120 is intended toform. Accordingly, in some particular embodiments the outer diameter ofthe core member 120 is approximately 0.014″, such as between 0.0138″ and0.0142″. In some embodiments the outer diameter of the core member 120is between about 0.0128″ and about 0.0135″ to allow for one or moreouter coating layers.

As also shown in FIG. 2, the core member 120 includes conductors 124embedded therein. In the illustrated embodiment, three conductors 124are embedded within the main body of the core member 120. In thatregard, the conductors 124 are fully encapsulated by the materialforming the main body of the core member 120. In some embodiments, aninsulating layer 126 is formed between the conductor 124 and the mainbody of the core member 120. To that end, the insulating layer 126 canbe utilized to electrically isolate the conductor 124 from the main bodyof the core member 120. As a result, each of the conductors 124 and/orthe main body of the core member 120 can be utilized as an independentelectrical communication pathway of the intravascular device 100.

The core member 120 can be formed of any suitable material such asstainless steel, nickel and titanium alloys (such as Nitinol),polyetheretherketone, 304V stainless steel, MP35N, or other metallic orpolymeric materials.

Each of the conductors 124 is formed of a conductive material, such ascopper, gold, silver, platinum, or other suitable conductive material.Generally, the size of the conductors 124 is selected to allow theconductors 124 to be fully embedded within the material forming the coremember 120, while still providing the appropriate conductive path forfunction of the component 108 of the intravascular device 100.Accordingly, in some instances the conductor is between a 24 AWGconductor and a 64 AWG conductor is utilized. In some instances, theconductor is between about 38 AWG and 52 AWG. 46 AWG and/or 48 AWGconductors are used in some implementations. The illustrated embodimentshows the conductors 124 being 46 AWG conductors. In other instances,larger or smaller conductors 124 are utilized. In certain embodiments,the conductors 124 are space substantially equally around acircumference of the main body of the core member 120. However, theconductors 124 may be embedded in any suitable manner and/or pattern,including symmetric, non-symmetric, geometric, and non-geometricpatterns.

As noted above, the insulating layer 126 serves to electrically isolatethe core member 120 from the conductors 124 and to isolate theconductors from one another. The insulating layer 126 may be formed ofany suitable material. In some instances, the insulating layer is apolymer layer. Generally, the insulating layer 126 may have any suitablethickness, but in some instances has a thickness between about 0.0001″and about 0.001″. In the illustrated embodiment, the insulating layer isshown as having a thickness of approximately 0.00025″. In someinstances, the conductors 124 are coated with the insulating layer 126prior to being embedded within the main body of the core member 120.That is, an insulated conductor is provided separately and then embeddedwithin the core member 120 during formation of the core member. In otherinstances, the main body of the core member 120, the insulating layer126, and conductors 124 are formed as part of an integrated process offorming the core member 120.

In some embodiments, additional conductors and/or other elements of theintravascular device are secured and/or wrapped around the core member120. For example, in some instances techniques such as those disclosedin U.S. patent application Ser. No. 14/143,304, filed Dec. 30, 2013,which is hereby incorporated by reference in its entirety.

Referring now to FIG. 3, shown therein is diagrammatic perspective viewof the core member 120 according to an embodiment of the presentdisclosure. In that regard, the core member 120 is shown with the distalportion 104 and proximal portion 106 having been shaped for use in theintravascular device 100. In particular, the distal portion 104 has beenshaped to expose the conductors 124 for electrical coupling to component108, facilitate coupling to one or more flexible members and/or a sensorhousing, facilitate physical coupling to the component 108, increase theflexibility of the distal tip of the intravascular device 102, and/orotherwise configure the characteristics of the distal portion of theintravascular device 102 for use.

In some embodiments, a coating 128 is provided on at least a portion ofthe outer surface 122 of the core member 120. In the illustratedembodiment, the coating 128 extends along a majority of the length ofthe core member 120 between the proximal portion 106 and the distalportion 104. The coating 128 can be a suitable hydrophilic orhydrophobic coating. In some implementations, the coating 128 providesincreased lubricity to the core member 120. Exemplary coating materialsinclude, without limitation, PTFE, PTFE impregnated polyimide,silicone-based coatings, and hydrophilic based coatings. Generally, thecoating 128 will be a very thin layer of material. For example, in someimplementations the coating 128 has a thickness less than about 0.0005″,less than about 0.0001″, and/or less than about 0.00005″.

Referring now to FIG. 4, shown therein is a diagrammatic, schematic sideview of the core member 120 of FIG. 3. As shown the main body of thecore member 120 has a diameter 130. Generally, the diameter 130 isapproximately equal to the maximum desired outer diameter of theintravascular device 100 with room left for lubricious coating.Accordingly, in some particular implementations the diameter 130 isabout 0.013″, 0.017″, or 0.034″. As shown, the distal portion 104 of thecore member 120 has been processed to include a portion 132 extendingdistally from the main body of the core member 120 and a portion 134extended distally from portion 132. In some instances, the portions132/134 are defined by grinding, etching, ablating, and/or otherwiseremoving surrounding portions of the core member 120.

In the illustrated embodiment, section 132 has a diameter 136 that isreduced relative to diameter 130 of the main body. In particular, insection 132 the outer portions of the core member 120 have been removedto expose the embedded conductors 124. By exposing the conductors 124,the component 108 can be electrically coupled to the conductors 124(e.g., using solder, leads, additional conductors (insulated in someinstances). Accordingly, in some instances, the diameter 136 of section132 is between about 30% and about 90% of the diameter 130, with someparticular embodiments being between about 70% and about 80% of thediameter 130. Accordingly, in some implementations, the diameter 136 ofsection 132 is between about 0.005″ and about 0.012″ for a 0.014″ outerdiameter intravascular device, with 0.010″ being utilized in someparticular embodiments; between about 0.005″ and about 0.016″ for a0.018″ outer diameter intravascular device, with 0.010″ being utilizedin some particular embodiments; and between about 0.005″ and about0.032″ for a 0.035″ outer diameter intravascular device, with 0.031″being utilized in some particular embodiments.

In the illustrated embodiment, section 134 has a diameter 138 that isreduced relative to diameter 136 of section 132. In particular, insection 134 the outer portions of the core member 120, including theembedded conductors 124, have been removed to reduce the stiffness andincrease the flexibility of the core member 120. Accordingly, in someinstances, the diameter 138 of section 134 is between about 10% andabout 80% of the diameter 130, with some particular embodiments beingbetween about 30% and about 60% of the diameter 130. Accordingly, insome implementations, the diameter 138 of section 134 is between about0.001″ and about 0.005″ for a 0.014″ outer diameter intravasculardevice, with 0.002″ being utilized in some particular embodiments;between about 0.001″ and about 0.008″ for a 0.018″ outer diameterintravascular device, with 0.003″ being utilized in some particularembodiments; and between about 0.0025″ and about 0.010″ for a 0.035″outer diameter intravascular device, with 0.007″ being utilized in someparticular embodiments.

In some instances, section 134 and/or section 132 are shaped in a mannerto facilitate coupling to additional elements of the intravasculardevice 100, including component 108, a housing for component 108,flexible members (coils, polymer tubes, and/or coil-embedded polymertubes), and/or combinations thereof. In that regard, while the sections132 and 134 are shown as having a constant diameter, in other instancesthe sections 132 and 134 include tapers, recesses, projections, and/orother structural features to facilitate coupling to other elements. Insome particular instances, the core member 120 is coupled to a distalsection, intermediate section, and/or proximal section similar to thosedescribed in one or more of U.S. Pat. Nos. 5,125,137, 5,873,835,6,106,476, 6,551,250, and U.S. patent application Ser. No. 13/931,052published as U.S. Patent Application Publication No. 2014/0005543 onJan. 2, 2014, U.S. patent application Ser. No. 14/143,304 published asU.S. Patent Application Publication No. 2014/0187874 on Jul. 3, 2014,each of which is hereby incorporated by reference in its entirety. Inthat regard, the component 108 can be mounted within a distal section ofthe intravascular device 100 using any suitable technique, includingwithout limitation those disclosed in one or more of U.S. Pat. No.5,125,137, 5,873,835, 6,106,476, 6,551,250, U.S. patent application Ser.No. 13/931,052, published as U.S. Patent Application Publication No.2014/0005543 on Jan. 2, 2014, U.S. patent application Ser. No.14/135,117 published as U.S. Patent Application Publication No.2014/0180141 on Jun. 26, 2014, U.S. patent application Ser. No.14/137,364, published as U.S. Patent Application Publication No.2014/0187980 on Jul. 3, 2014, and U.S. patent application Ser. No.14/139,543, published as U.S. Patent Application Publication No.2014/0187984 on Jul. 3, 2014, each of which is hereby incorporated byreference in its entirety.

In some implementations, the conductors 124 are exposed for electricalcoupling to component 108 at an end surface extending perpendicular tothe longitudinal axis of the core member 120. That is, the conductors124 are not exposed along the length of the core member 120 (as shown inFIG. 4), but rather are exposed at an end surface of the core member 120(similar to what is shown in FIG. 2), which may occur at intermediatetransition point(s), such as the end of main body or end of section 132and/or an end of the core member. In such instances, reduced diametersection(s) 106 and/or 132 may be omitted. For example, where the coremember 120 is utilized as a drive cable in an intravascular ultrasound(IVUS) device, these reduced diameter section(s) may be eliminated.

As shown, the proximal portion 106 of the core member 120 has beenprocessed to include a portion 140 extending proximally from the mainbody of the core member 120. In some instances, the portion 140 isdefined by grinding, etching, ablating, and/or otherwise removingsurrounding portions of the core member 120. In the illustratedembodiment, section 140 has a diameter 142 that is reduced relative todiameter 130 of the main body. In particular, in section 140 the outerportions of the core member 120 have been removed to expose the embeddedconductors 124. By exposing the conductors 124, one or more connectorscan be electrically coupled to the conductors 124 (e.g., using solder,leads, additional conductors (insulated in some instances) to defineconnector 110 of the intravascular device 100. As a result, the diameter142 of section 140 can be the same as the diameter 136 of section 132 insome instances. Accordingly, in some implementations, the diameter 142of section 140 is between about 0.005″ and about 0.012″ for a 0.014″outer diameter intravascular device, with 0.010″ being utilized in someparticular embodiments; between about 0.005″ and about 0.016″ for a0.018″ outer diameter intravascular device, with 0.010″ being utilizedin some particular embodiments; and between about 0.005″ and about0.032″ for a 0.035″ outer diameter intravascular device, with 0.031″being utilized in some particular embodiments.

Referring now to FIG. 5, shown therein is the proximal portion 106 ofthe intravascular device 100 formed over the core member 120 of FIGS. 3and 4 according to an embodiment of the present disclosure. As shown,three conductive bands 144 are separated by insulators 146 to defineconnector 110 of the intravascular device 100. In some instances, theconductive bands 144 are printed onto the core member 120 byelectrically printing or plating of a conductive material over theexposed portions of the conductors 124. In that regard, the conductivebands 144 are formed such that they have a uniform outer diametermatching the desired outer diameter of the intravascular device and/orthe outer diameter of connector in some implementations. To facilitateformation of each of the conductive bands 144 in an electricallyisolated manner relative to the other conductors 124, the embeddedconductors 124 are exposed and then coated with an insulator material,such as polyimide. Then each individual conductor 124 is exposed (e.g.,via laser ablation) at staggered locations along the length of the coremember 120 that represent where the conductive bands 144 will be formed.In this manner, each conductive band 144 is electrically coupled to asingle conductor 124 and electrically isolated from the remainingconductors 124. If desired, it is possible to electrically couple aconductive band 144 to more than one of the conductors 124.

Any desired pattern of conductive material may be placed onto the coremember 120 to define the conductive bands 144. For example, theconductive bands 144 can be solid, multiple rings, a spiral, and/or anyother pattern that provides the optimum functionality. In someinstances, the conductive bands 144 are preformed cylindrical membersthat are positioned over the corresponding exposed sections of theconductors 124 and electrically coupled to the conductors using solderor other suitable techniques. In some embodiments, the conductive bandsare swaged and/or laser welded in place. The insulating materialutilized for insulators 146 may be any suitable insulating material.

In the illustrated embodiment, each of the three conductive bands 144 iselectrically coupled to a single one of the conductors 124 andelectrically isolated from the others (e.g., by one or more insulatinglayers). In some instances, the conductors 124 are exposed from the coremember 120 only in locations along the length of the core member wherethe conductor 124 is to be coupled to the conductive band. A referencering may be formed at a proximal or distal end of the core member 120 todetermine where the conductors 124 are positioned relative to thecircumference/outer surface of the core member 120 to facilitateselective exposure of only portions of the conductors 124. Those skilledin the art will recognize that there are numerous ways for electricallycoupling the conductive bands 144 to the conductors 124 in an isolatedmanner. Further, it should be noted that in some instances an additionalconductive band is provided and electrically coupled to the core member120. In yet other instances, a portion of the core member 120 itselfdefines a conductive band.

Referring now to FIG. 6, shown therein is the distal portion 104 of theintravascular device 100 formed over the core member 120 of FIGS. 3 and4 according to an embodiment of the present disclosure. As shown, thedistal portion 104 includes a flexible element 150 extending from themain body of the core member 120 over sections 132 and 134 to thecomponent 108 (or a housing containing component 108). In that regard,the flexible element 150 may be a coil, a polymer tubing, and/or acoil-embedded polymer tubing. The distal portion 104 also includes aflexible element 152 extending distally from the component 108 (or ahousing containing component 108) to the distal tip 105 of theintravascular device 100. Again, the flexible element 152 may be a coil,a polymer tubing, and/or a coil-embedded polymer tubing. In someinstances, the flexible element 152 is radiopaque and/or includes aradiopaque tip. In some implementations, a flow sensor is positioned atthe distal tip 105 of the intravascular device 100. Generally, thedistal portion 104 of the intravascular device 100 may include featuressimilar to those described in any of the patents and applicationsincorporated by reference above, but utilizing the core member 120 ofthe present disclosure having embedded conductors 124 as the core wireof the intravascular device.

As also shown in FIG. 6, the distal portion 104 can include one or moreradiopaque markers 154. In that regard, the radiopaque markers 154 canbe utilized to facilitate co-registration of the measurements obtainedwith the intravascular device 100 to corresponding images of the vessel,including angiography, x-ray, CT scans, IVUS, OCT, and/or other imagingmodalities. In some implementations, co-registration is performed asdisclosed in one or more of U.S. Pat. No. 7,930,014, U.S. patentapplication Ser. No. 14/144,280, published as U.S. Patent ApplicationPublication No. 2014/0187920 on Jul. 3, 2014, U.S. patent applicationSer. No. 14/335,603 published as U.S. Patent Application Publication No.2014/0025330 on Jan. 22, 2015, and U.S. Provisional Patent ApplicationNo. 61/895,909 filed Oct. 25, 2013 titled “DEVICES, SYSTEMS, AND METHODSFOR VESSEL ASSESSMENT”, each of which is hereby incorporated byreference in its entirety.

The radiopaque markers 154 can be formed of any radiopaque material. Insome instances, the radiopaque markers 154 are coils formed of aradiopaque material. There may be any number of radiopaque markers 154,including one, two (as shown), three, or more. In some implementations,the radiopaque markers 154 are located proximal of the component 108 andits associated housing, if any. Further, in some instances theradiopaque markers 154 are elongated such that they have a greaterlength than typical balloon or stent markers, to allow the radiopaquemarkers 154 of the intravascular device 100 to be distinguished from themarkers of other elements that may be positioned in the same region ofthe vessel. In some instances, the radiopaque markers 154 have a lengthalong the longitudinal axis of the intravascular device 100 of betweenabout 3 mm and about 10 mm, with some particular implementations havinga length of about 5 mm.

As discussed above with respect to component 108, the sensor(s) of theintravascular device 100 provide a mechanism to obtain intraluminalmeasurements within a body lumen and are connected to the one or moreconductive bands on the intravascular device, which transmit and receivesignals from the sensor(s). For example, the guide wire of the presentdisclosure can include a pressure sensor, a flow sensor, a temperaturesensor or combinations thereof. The guide wire can be a combinationguide wire that includes both a pressure sensor and a flow sensor.Pressure sensors can be used to measure pressure within the lumen andflow sensors can be used to measure the velocity of blood flow.Temperature sensors can measure the temperature of a lumen. A guide wirewith both a pressure sensor and a flow sensor provides a desirableenvironment in which to calculate fractional flow reserve (FFR) or otherpressure ratio calculations using pressure readings, and coronary flowreserve (CFR) using flow readings. Guide wires with two or more sensorscan be made by increasing the number of conductive wires embedded withinthe core member. In addition, the core member 120 may also be utilizedas a conductor in some embodiments. Such embodiments provide enoughconductive pathways to facilitate the use of at least two sensors withthe intravascular device 100.

The ability to measure and compare both the pressure and velocity flowand create an index of hyperemic stenosis resistance significantlyimproves the diagnostic accuracy of this ischemic testing. It has beenshown that distal pressure and velocity measurements, particularlyregarding the pressure drop-velocity relationship such as FractionalFlow reserve (FFR), Coronary flow reserve (CFR) and combined P-V curves,reveal information about the stenosis severity. For example, in use, theguide wire may be advanced to a location on the distal side of thestenosis. The pressure and flow velocity may then be measured at a firstflow state. Then, the flow rate may be significantly increased, forexample by the use of drugs such as adenosine, and the pressure and flowmeasured in this second, hyperemic, flow state. The pressure and flowrelationships at these two flow states are then compared to assess theseverity of the stenosis and provide improved guidance for any coronaryinterventions. The ability to take the pressure and flow measurements atthe same location and same time with the combination tip sensor,improves the accuracy of these pressure-velocity loops and thereforeimproves the accuracy of the diagnostic information.

A pressure sensor can be mounted, for example, on a distal portion ofthe guide wire. The pressure sensor can be formed of a crystalsemiconductor material having a recess therein and forming a diaphragmbordered by a rim. A reinforcing member is bonded to the crystal andreinforces the rim of the crystal and has a cavity therein underlyingthe diaphragm and exposed to the diaphragm. A resistor having oppositeends is carried by the crystal and has a portion thereof overlying aportion of the diaphragm. Electrical conductor wires of the senor areconnected to a conductive band in the guide wire. Additional details ofsuitable pressure sensors that may be used with devices of the presentdisclosure are described in U.S. Pat. Nos. 6,106,476. 6,106,476 alsodescribes suitable methods for coupling the pressure sensor to a guidewire. Those methods are applicable to coupling the sensor to theconductive bands in guide wires of the present disclosure.

In certain aspects, the guide wire of the present disclosure includes aflow sensor. The flow sensor can be used to measure blood flow velocitywithin the vessel, which can be used to assess coronary flow reserve(CFR). The flow sensor can be, for example, an ultrasound transducer, aDoppler flow sensor or any other suitable flow sensor, disposed at or inclose proximity to the distal tip of the guide wire. The ultrasoundtransducer may be any suitable transducer, and may be mounted in thedistal end using any conventional method, including the manner describedin U.S. Pat. Nos. 5,125,137, 6,551,250 and 5,873,835.

Guide wires of the present disclosure can be connected to an instrument,such as a computing device (e.g. a laptop, desktop, or tablet computer)or a physiology monitor, that converts the signals received by thesensors into pressure and velocity readings. The instrument can furthercalculate Coronary Flow Reserve (CFR) and Fractional Flow Reserve (FFR)and provide the readings and calculations to a user via a userinterface. In some embodiments, a user interacts with a visual interfaceto view images associated with the data obtained by the intravasculardevices of the present disclosure. Input from a user (e.g., parametersor a selection) are received by a processor in an electronic device. Theselection can be rendered into a visible display.

Persons skilled in the art will also recognize that the apparatus,systems, and methods described above can be modified in various ways.Accordingly, persons of ordinary skill in the art will appreciate thatthe embodiments encompassed by the present disclosure are not limited tothe particular exemplary embodiments described above. In that regard,although illustrative embodiments have been shown and described, a widerange of modification, change, and substitution is contemplated in theforegoing disclosure. It is understood that such variations may be madeto the foregoing without departing from the scope of the presentdisclosure. Accordingly, it is appropriate that the appended claims beconstrued broadly and in a manner consistent with the presentdisclosure.

What is claimed is:
 1. A sensing guide wire, comprising: a flexibleelongate member sized and shaped to be inserted into a blood vessel of apatient, wherein the flexible elongate member comprises a core wirehaving a solid cross section, a proximal portion, a distal portion, anda main body extending between the proximal portion and the distalportion; a sensing element disposed at the distal portion of theflexible elongate member and configured to measure a characteristicassociated with the blood vessel while positioned inside the bloodvessel; and at least two non-coaxial electrical conductors incommunication with the sensing element, wherein the at least twonon-coaxial electrical conductors are spaced apart from one another andextend from the proximal portion to the distal portion, wherein, in themain body, the at least two non-coaxial electrical conductors arecompletely disposed within the solid cross section of the core wire, andwherein, at the proximal portion and the distal portion, the at leasttwo non-coaxial electrical conductors are exposed.
 2. The sensing guidewire of claim 1, further comprising a lubricating coating over the corewire along a majority of a length between the proximal portion and thedistal portion.
 3. The sensing guide wire of claim 1, wherein, at theproximal portion, the at least two non-coaxial electrical conductors areexposed at staggered longitudinal positions.
 4. The sensing guide wireof claim 1, wherein the sensing element comprises at least one of apressure sensor, a flow sensor, a temperature sensor, or a combinationthereof.
 5. The sensing guide wire of claim 1, further comprising afirst flexible element extending from the main body, over the distalportion, to the sensing element.
 6. The sensing guide wire of claim 5,wherein the first flexible element comprises at least one of a coil, apolymer tubing, or a coil embedded polymer tubing.
 7. The sensing guidewire of claim 5, further comprising a second flexible element extendingdistally from the sensing element.
 8. The sensing guide wire of claim 7,wherein the second flexible element comprises at least one of a coil, apolymer tubing, or a coil embedded polymer tubing.
 9. The sensing guidewire of claim 7, wherein the second flexible element comprises aradiopaque tip.
 10. The sensing guide wire of claim 7, wherein thesecond flexible element is radiopaque.
 11. The sensing guide wire ofclaim 1, wherein the proximal portion of the core wire comprises a firstdiameter, wherein the main body of the core wire comprises a seconddiameter greater than the first diameter, and wherein the distal portionof the core wire comprises a third diameter smaller than the seconddiameter.
 12. The sensing guide wire of claim 11, wherein the firstdiameter and the third diameter are between about 30% and about 90% ofthe second diameter.
 13. The sensing guide wire of claim 11, wherein thesecond diameter is between about 0.013″ and about 0.034″.
 14. Thesensing guide wire of claim 11, wherein the first diameter and the thirddiameter are between 0.005″ and about 0.032″.
 15. The sensing guide wireof claim 11, wherein the distal portion of the core wire furthercomprises a first distal portion and a second distal portion distal tothe first distal portion, and wherein the first distal portion comprisesthe third diameter and the second distal portion comprises a fourthdiameter smaller than the third diameter.
 16. The sensing guide wire ofclaim 15, wherein the fourth diameter is between about 10% and about 80%of the second diameter.
 17. The sensing guide wire of claim 1, whereinthe core wire comprises a metal.
 18. The sensing guide wire of claim 1,wherein the core wire comprises a solid cylindrical body.